KR20230021671A - CATHETER WITH VARIABLE LENGTH EXTENSION LEG - Google Patents

Abstract

A catheter assembly for constructing a catheter system is disclosed. The catheter assembly can include a molded hub, a catheter tube connected to a distal end of the molded hub, a plurality of extension legs having a distal end connected to the molded hub, and a securing mechanism. The molded hub may include a pair of hub lumens that form a hub portion of a pair of fluid pathways through the catheter assembly. The catheter tube may include a pair of catheter tube lumens. The securing mechanism may be configured to secure the plurality of extension legs together. The securing mechanism may be in the form of a slidable collar comprising a proximal opening and a distal opening, the slidable collar disposed over the plurality of extending legs.

Description

CATHETER WITH VARIABLE LENGTH EXTENSION LEG

The present disclosure relates to catheter assemblies, and more particularly to a catheter assembly for constructing and securing a plurality of extension legs and a method for fabricating a catheter assembly for constructing and securing a plurality of extension legs.

In current catheters, the extension legs are only fixed to the hub and can move freely proximal to the hub. The extension legs contain clamps and Luer locks, making them bulky and often difficult to secure them together. This can be frustrating for healthcare professionals and patients who need to perform dressing changes at catheter sites, and can result in improper occlusive seal placement at catheter sites. A solution currently does not exist to assist the healthcare professional in securing the extension legs proximal from the hub together so that the healthcare professional can focus on changing the dressing.

US Patent Publication US2008-0306465A1 presents an adjustable length catheter device.

Disclosed herein are catheter assembly systems and methods of use and manufacture thereof. The disclosed embodiments of catheter assembly systems provide several advantages over conventional catheter assembly systems. In particular, embodiments of the present disclosure allow a medical professional to easily secure a plurality of extension legs of a catheter assembly system. This is advantageous during normal use and while attempting to form a closure seal at the catheter entry site, as it provides comfort and convenience to the patient.

In some embodiments, a catheter assembly is shown for constructing a catheter system comprising a molded hub comprising at least one pair of hub lumens; a catheter tube connected to the distal end of the molded hub, the catheter tube including at least one pair of catheter tube lumens; a plurality of extension legs each comprising a distal end connected to a proximal end of the molded hub, wherein a fluid path is formed between the catheter tube and the plurality of extension legs through the pair of hub lumens; and a securing mechanism configured to secure the plurality of extending legs together, the securing mechanism being a slidable collar positioned on the plurality of extending legs.

In some embodiments, the slidable collar is a permanent slidable collar comprising a length, width and height and having a proximal end with a proximal opening, a distal end with a distal opening, an outer surface and an inner surface. .

In some embodiments, the length has a dimension greater than or equal to the width, and the width has a dimension greater than or equal to the height. In some embodiments, the outer surface slopes toward the inner surface at an intermediate point in the longitudinal direction and slopes away from the inner surface toward an end point in the longitudinal direction. In some embodiments, the inner surface is configured to form friction with the exterior of the extending legs, and the friction resists movement of the slidable collar in the absence of an external force applied to the slidable collar. . In some embodiments, the proximal opening and the distal opening have an oval shaped configuration.

In some embodiments, a catheter assembly is shown for constructing a catheter system, the catheter assembly comprising a molded hub comprising at least one pair of hub lumens, the hub lumen being a pair of fluid pathways through the catheter assembly. form the hub portion of the -; a catheter tube connected to the distal end of the molded hub, the catheter tube including at least one pair of catheter tube lumens; a plurality of extension legs each comprising a proximal end and a distal end, the distal end of each of the extension legs connected to the molded hub; and a securing mechanism configured to secure the plurality of elongated legs together, including an adhesive bond between the plurality of elongated legs, or at least one of an attachable slidable collar or a permanent slidable collar. . The securing mechanism may include the adhesive bond between the plurality of extending legs. In some embodiments, the securing mechanism is the attachable slidable collar.

In some embodiments, the attachable slidable collar is releasably connected to the molded hub. In some embodiments, the attachable slidable collar or permanent slidable collar is positioned on the plurality of extending legs. In some embodiments, the fixation mechanism is the attachable slidable collar or the permanent slidable collar, and the fixation mechanism has a length, a width, a height, a proximal end with a proximal opening, a distal end with a distal opening. It includes an end, a midpoint in the longitudinal direction, an end point in the longitudinal direction, an outer surface and an inner surface.

In some embodiments, the length has a dimension greater than or equal to the width, and the width has a dimension greater than or equal to the height. In some embodiments, the outer surface slopes toward the inner surface at a midpoint in the longitudinal direction and slopes away from the inner surface towards an end point in the longitudinal direction. In some embodiments, the inner surface is configured to form friction with the outside of the extending legs, and the friction, in the absence of an external force applied to the attachable slidable collar, causes a friction of the attachable slidable collar. resist movement; In some embodiments, the proximal opening and the distal opening are elliptical in shape.

In some embodiments, the fixation mechanism can be axially separated into two separate sections. In some embodiments, the anchoring mechanism is engaged at a midpoint in the longitudinal direction. In some embodiments, the securing mechanism is joined together by a first hinge and a first snap opposite the first hinge. In some embodiments, the securing mechanism is joined together by a first clasp and a second clasp opposite the first clasp. In some embodiments, the locking mechanism is coupled together by a first pair of magnets and a second pair of magnets opposite the first pair of magnets.

In some embodiments, a method of fabricating a catheter assembly for constructing a catheter system is disclosed. The method includes obtaining a molded hub comprising at least a pair of hub lumens, each of the hub lumens having an entry point adjacent or substantially adjacent to another entry point; obtaining a catheter tube, the catheter tube comprising at least one pair of catheter tube lumens; obtaining a plurality of extension legs; obtaining a securing mechanism for securing the plurality of extension legs together, the securing mechanism selected from the group consisting of an adhesive bond, a permanent slidable collar, and an attachable slidable collar; connecting the catheter tube to the distal end of the molded hub, connecting the distal end of each of the plurality of extension legs to the proximal end of the molded hub - the catheter tube and the catheter tube through the pair of hub lumens. a fluid path is formed between the plurality of extension legs; securing the plurality of extension legs together using the securing mechanism, and packaging the catheter assembly in disposable packaging.

In some embodiments, securing the plurality of extension legs together using the securing mechanism further comprises curing the plurality of extension legs together using heat to form the adhesive bond. . In some embodiments, securing the plurality of extension legs together using the securing mechanism includes coating the plurality of extension legs with an adhesive and heat, pressure or heat to form the adhesive bond. A step of curing using a combination thereof is further included.

In some embodiments, securing the plurality of extension legs together using the securing mechanism further includes attaching the permanent slidable collar. In some embodiments, securing the plurality of extension legs together using the securing mechanism further includes attaching the attachable slidable collar.

These and other features of the concepts presented herein will become more apparent to those skilled in the art from the accompanying drawings and the following description, which more specifically describe specific embodiments of the concepts.

Embodiments of the present disclosure are described by way of example and not limitation in the accompanying drawings in which like reference numbers indicate like elements.
1 shows an exemplary diagram of a catheter assembly in accordance with some embodiments.
2A and 2B show example views of a catheter assembly for constructing a catheter system that includes a securing mechanism that further includes an adhesive bond according to some embodiments.
3A and 3B show example views of a catheter assembly for constructing a catheter system that includes a securing mechanism that further includes a permanent, slidable collar, according to some embodiments.
4A and 4B show example views of a catheter assembly for constructing a catheter system that includes a securing mechanism that further includes an attachable slidable collar in accordance with some embodiments.
5A and 5B show a method used to construct a plurality of extension legs according to some embodiments.
6A and 6B show alternative embodiments of slidable collars according to some embodiments.
7 illustrates a flow diagram illustrating a method for fabricating a catheter assembly for constructing a catheter system according to some embodiments.
8 shows a catheter assembly including a slideable collar secured to a patient using a dressing, in accordance with some embodiments.
9A and 9B are perspective views of an anchoring system according to some embodiments.

This patent application claims the benefit of priority to US patent application Ser. No. 63/036,899, filed on June 9, 2020, the aforementioned US patent application being incorporated herein by reference.

Before discussing some specific embodiments in detail, it should be understood that the specific embodiments disclosed herein do not limit the scope of the concepts presented herein. It is also to be understood that a particular embodiment disclosed herein may have features that are readily separable from that particular embodiment, and that can be optionally combined with or substituted for features of any number of other embodiments disclosed herein. There will be.

With respect to the terms used herein, it should be understood that the terms are for the purpose of describing some specific embodiments and that the terms do not limit the scope of the concepts presented herein. Ordinal numbers (e.g., 1st, 2nd, 3rd, etc.) are generally used to distinguish or identify different features or steps within a group of features or steps, and do not provide serial or numerical limitations. no. For example, “first”, “second”, and “third” features or steps do not necessarily appear in that order, and a particular embodiment incorporating such features or steps necessarily includes all three features or steps. It need not be limited to steps. Labels such as “left”, “right”, “top”, “bottom”, “anterior”, “rear”, etc. are used for convenience and imply, e.g., any particular fixed location, orientation, or direction. It is not intended to Instead, such labels are used, for example, to reflect relative position, orientation, or direction. Unless the context clearly dictates otherwise, the singular forms “a,” “an,” and “the” include the singular and/or plural.

With reference to "proximal", for example, the "proximal portion" or "proximal end portion" of a catheter disclosed herein refers to the portion of a catheter intended to be in proximity to a clinician when the catheter is used on a patient. include Likewise, for example, the "proximal length" of a catheter includes the length of the catheter intended to be close to the clinician when the catheter is used on a patient. For example, the "proximal end" of the catheter includes the end of the catheter that is intended to be proximate to the clinician when the catheter is used on a patient. The proximal portion, proximal end portion, or proximal length of the catheter may include the proximal end of the catheter; The proximal portion, proximal end portion, or proximal length of the catheter need not include the proximal end of the catheter. That is, unless the context indicates otherwise, the proximal portion, proximal end portion, or proximal length of the catheter is not the distal portion or distal length of the catheter.

With reference to "distal", for example, the "distal portion" or "distal end portion" of a catheter disclosed herein is intended to be positioned proximate to or within a patient when the catheter is used with respect to a patient. Includes part of the catheter. Likewise, for example, the "distal length" of a catheter includes the length of the catheter intended to be positioned proximate to or within the patient, when the catheter is used with respect to the patient. For example, the “distal end” of a catheter includes the end of a catheter intended to be positioned proximate to or within a patient when the catheter is used on a patient. The distal portion, distal end portion, or distal length of the catheter may include the distal end of the catheter; The distal portion, distal end portion, or distal length of the catheter need not include the distal end of the catheter. That is, unless the context indicates otherwise, the distal portion, distal end portion, or distal length of the catheter is not the distal portion or distal length of the catheter.

Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of skill in the art.

1 shows a molded hub 102, clamp 114, and Luer connections 112 that accommodate a plurality of extension legs 106, the clamps 114 and Luer connections 112 comprising: Connected to a plurality of extension legs (106). A catheter tube 104 containing a catheter tip 110 is connected to the molded hub 102 . The plurality of extension legs 106 are not connected together along the length 108 of the plurality of extension legs 106, which means that the clamps 114 and Luer connections 112 do not connect the plurality of extension legs 106. ) to move laterally along each of the When performing a dressing change, the healthcare professional often inserts a plurality of extension legs 106, clamps 114 and Luer connections 112 at the catheter entry site while attempting to form a closure seal at the catheter entry site. It needs to be fixed proximal. Forming a closure seal is important in maintaining sterility and ensuring that the catheter entry site is not infected. Constructing and securing the plurality of extension legs 106, clamps 114 and Luer connections 112 may also increase patient comfort.

Catheter assembly with adhesive bond

FIG. 2A shows an exemplary diagram of a catheter assembly for constructing a catheter system 200 having extension legs connected via adhesion binding. In FIG. 2A , molded hub 202 is connected to catheter tube 208 containing catheter tip 210 . A plurality of extension legs 212 are connected to the molded hub 202, with clamps 204 and Luer connections 206 disposed thereon. A securing mechanism 214 , eg adhesive binding, secures and configures the plurality of extension legs 106 along the proximal proximal length of the plurality of extension legs 216 of the molded hub 102 .

Molded hub 202 can include at least one pair of hub lumens, one example including an arterial lumen and a venous lumen. However, the embodiments are not intended to be limited to such examples. Additionally, catheter tube 208 may include at least one pair of catheter tube lumens and may be connected to a distal end of molded hub 202 . The distal end of each of the plurality of extension legs 212 can be connected to the proximal end of the molded hub 202 and the fluid path is passed through the pair of hub lumens to the plurality of extension legs 212 and the catheter tube 208. ) can be formed between

Referring now to FIG. 2B , the catheter assembly 200 of FIG. 2A is shown in which at least a portion of the adhesive bond is interrupted, and thus at least a portion of the extension legs are separated. In some embodiments, the adhesive bond may be interrupted through the application of a force to pull apart two or more of the extension legs 212 . Adhesive bond 214 may be disposed at various lengths along plurality of extending legs 212 . For example, in some embodiments, adhesive bond 214 can adhere plurality of extension legs 212 together from molded hub 202 to at least a majority of the length of extension legs 212 .

In some embodiments, adhesive bond 214 releasably binds at least one extension leg to another extension leg, thereby enabling separation of at least one of plurality of extension legs 212 . The adhesive bond 214 between the plurality of extension legs 212 may be detached through an external force. For example, in some embodiments, the medical professional secures the other Luer connectors 206 connected to the plurality of remaining extension legs 212 proximally (or otherwise away from the remaining extension legs 212). While doing so, the Luer connectors 206 connected to the extension leg 212 can be pulled distally towards the molded hub 202 . In some examples, at least one extension leg may be detachable. In another example, one or more extension legs may not be detachable. In some examples, plurality of extension legs 212 may be isolated by detaching one or more extension legs. For example, in some embodiments, catheter assembly 200 may include a plurality of extension legs 212 including, but not limited to, at least three extension legs. In some embodiments, at least but without limitation one Luer connection 206 connected to one of the extension legs 212 while securing an additional two Luer connections 206 connected to the two extension legs 212. ) and pull distally towards the molded hub 202, thereby separating the plurality of extension legs 212 into two distinct plurality of extension legs 212. . It should be understood that any number of extension legs that may be included in various embodiments of catheter assembly 200 and in the figures provided herein are not intended to be limiting.

Catheter assembly with collar

3A shows a catheter assembly 300 that includes a molded hub 302 connected to a catheter tube 308 that includes a catheter tip 310 . In some embodiments, the molded hub 302 is connected to a plurality of extension legs 312, the plurality of extension legs 312 having clamps 306 and Luer connections 304 disposed thereon. have In some embodiments, the catheter assembly 300 optionally further includes a securing mechanism, which secures the plurality of extension legs 312 proximate the molded hub 302 together. and an adhesive bond 314 between the sills 312 . The securing mechanism, in some embodiments, includes an adhesive bond 314, or a permanent slidable collar 316, or a combination thereof.

3B shows the permanent slidable collar 316 of FIG. 3A, which has a length 318, a width 320, a height 322, a proximal end, a proximal opening 324, a distal It includes an end, a distal opening 326 , a midpoint 332 in the longitudinal direction, an end point 334 in the longitudinal direction, an outer surface 328 , and an inner surface 330 . In some embodiments, length 318 may be in the range of 6 to 30 millimeters (mm). In some embodiments, width 320 can be in the range of 6-30 mm. In other embodiments, the width 320 may be varied to accommodate the plurality of extension legs 312 depending on the specific embodiment. Height 322 may be in the range of 6 to 30 mm. In some embodiments, the height 322 can be varied to accommodate the plurality of extension legs 312 . Proximal opening 324 and distal opening 326 may be, but are not limited to, an elliptical shaped configuration. In some embodiments, proximal opening 324 and distal opening 326 are shaped including circles, rectangles, squares, polygons (including hexagons, heptagons, octagons, nongons, or decagons in some embodiments). configuration can be included. The proximal opening 324 may include the same shape configuration as the distal opening 326 . In some cases, the proximal opening 324 can include a shape configuration that is different from the shape configuration of the distal opening 326 . In some embodiments, the midpoint 332 in the longitudinal direction is located in the middle of the length 318 of the permanent slidable collar 316 . As shown in FIG. 3B , the end point 334 in the longitudinal direction is located at the distal end of the permanent slidable collar 316 .

In some embodiments, the outer surface 328 slopes from the proximal end in the direction of the inner surface 330 towards the midpoint 332 in the longitudinal direction. In some embodiments, the outer surface 328 slopes from a midpoint 332 in the longitudinal direction toward an end point 334 in the longitudinal direction located at a distal end away from the direction of the inner surface 330 . In some embodiments, the permanent slidable collar 316 is formed with a continuous curve between the proximal and distal ends. For example, the outer surface 328 slopes in the direction of the inner surface 330 from the proximal end 324 to a point located at the midpoint 332 in the longitudinal direction, then the midpoint 332 in the longitudinal direction. ) slopes toward an endpoint 334 in the longitudinal direction located at the distal end away from the direction of the inner surface 330 .

In some embodiments, interior surface 330 extends along length 318 to an end point 334 in the longitudinal direction located at the distal end. The inner surface 330 is configured to contact an outer surface of the plurality of extending legs 312 . In some embodiments, inner surface 330 is configured to form friction with the exterior of extending legs 312 . This friction prevents the permanent slidable collar 316 from moving distally in the absence of an external force.

In an alternative embodiment, not shown in the drawings, the outer surface 328 does not slope to a longitudinal midpoint 332, but to a longitudinal end point 334 located at a distal end along length 318. ) sloped up to In other words, the outer surface 328 of the permanent slidable collar 316 is flat from the proximal end to the distal end.

In yet another embodiment, the lower side of collar 316 may include an adhesive arranged to adhere to the patient's skin. In this embodiment, the lower side of collar 316 may additionally include a removable liner initially disposed over the adhesive. The liner may include a pull tab that allows the medical professional to remove the liner to expose the adhesive. For example, the liner may be formed of paper and/or plastic.

4A shows a catheter assembly 400, which in some embodiments includes a molded hub 402 connected to a catheter tube 408 that includes a catheter tip 410. . In some embodiments, molded hub 402 is connected to a plurality of extension legs 412 , which include clamps 406 and Luer connections 404 . In some embodiments, the catheter assembly 400 further includes a securing mechanism, which secures the plurality of extension legs 412 proximal to the molded hub 402 together. and an adhesive bond 414 between (412). The securing mechanism, in some embodiments, further comprises an adhesive bond 414, or an attachable slidable collar 416 or a combination thereof.

4B shows, in some embodiments, an attachable slidable collar 416 that has a length 418, a width 420, a height 422, a proximal end, a proximal opening ( 424 ), a distal end, a distal opening 426 , a midpoint 432 in the longitudinal direction, an end point 436 in the longitudinal direction, an outer surface 428 , and an inner surface 430 . Length 418 may be in the range of 6 to 30 mm. Width 420 may be in the range of 6 to 30 mm. To accommodate the plurality of extension legs 412, the width 420 can be varied. In some embodiments, height 422 can be in the range of 6-30 mm. In some embodiments, height 422 may be varied to accommodate a plurality of extension legs 412 depending on the specific embodiment. In some embodiments, proximal opening 424 and distal opening 426 may include, but are not limited to, oval shaped configurations. In some embodiments, proximal opening 424 and distal opening 426 are shaped including circles, rectangles, squares, polygons (including hexagons, heptagons, octagons, nongons, or decagons in some embodiments). configuration can be included. In some embodiments, proximal opening 424 can include the same shape configuration as distal opening 426 . In some embodiments, the proximal opening 424 can include a shape configuration that is different from the shape configuration of the distal opening 426 . As shown in FIG. 4B , midpoint 432 in the longitudinal direction is located midway along length 418 . In some embodiments, end point 436 in the longitudinal direction is located at the distal end.

In some embodiments, the attachable slidable collar 416 is formed with a continuous curve between the proximal and distal ends. In some embodiments, the outer surface 428 slopes from the proximal end in the direction of the inner surface 430 towards the midpoint 432 in the longitudinal direction. In some embodiments, the outer surface 428 has an end point 436 in the longitudinal direction located at the distal end of the attachable slidable collar away from the direction of the inner surface 430 from the midpoint 432 in the longitudinal direction. ) slopes toward In some embodiments, outer surface 428 can be inclined in one or more directions throughout length 418 . For example, the shape of outer surface 428 can be configured to slope in a first direction throughout length 418 from a proximal or distal end to a point (eg, midpoint 432 ).

As one non-limiting example, the outer surface 428 slopes in the direction of the inner surface 430 from the proximal end to a point located at the midpoint 432 in the longitudinal direction, then the midpoint in the longitudinal direction ( 432 slopes toward an end point 436 in the longitudinal direction located at the distal end of the attachable slidable collar 416 away from the direction of the inner surface 430 . In some embodiments, the outer surface 428 slopes in the direction of the inner surface 430 from the proximal end but does not slope to a point located at the midpoint 432 in the longitudinal direction, and instead, in some embodiments , the end point in the longitudinal direction located at the distal end of the attachable slidable collar 416 progressively sloping to the longitudinal midpoint 432 and progressively distal from the longitudinal midpoint 432. It slopes to (436). In some embodiments, the outer surface 428 is not sloped to the midpoint 432 in the longitudinal direction and is located at the distal end of the slidable collar 416 attachable along the length 418. It extends to the end point 436. In other words, the outer surface of the attachable slidable collar 416 is flat from the proximal end to the distal end. In some embodiments, interior surface 430 extends along length 418 to end point 436 in the longitudinal direction located at distal end 426 of attachable slidable collar 416 . In some embodiments, inner surface 430 can physically contact an outer surface of plurality of extending legs 412 . In some embodiments, inner surface 430 is configured to form friction with the exterior of extending legs 412, such that friction is such that permanent slidable collar 416 is free from external force applied thereto. state, prevent movement.

In some embodiments, the attachable slidable collar 416 can be further separated axially into two pieces 416A and 416B, which pieces 416A and 416B may include, for example but not limited to , which are configured to be attached together at an intermediate point 432 in the longitudinal direction by a clasping mechanism 434, which may include any or combination of clasps, hinges, snaps, magnets, and the like. In some embodiments, as shown in FIG. 4B , the clasping mechanism 434 disposed on the piece 416A can be a static clasp that includes a snap hook 435 at the distal end, and the snap hook 435 ) is configured to be received in the groove 437 disposed on the pieces 416B. In some embodiments, a first clasping mechanism 434 can be located at an intermediate point 432 in the longitudinal direction on a first side while a second clasping mechanism 434 is positioned on a second side (not shown). ) at an intermediate point 432 in the longitudinal direction.

In some embodiments, as described above with respect to the slidable collar 316, the slidable collar 416 may include a lower side and may have an adhesive and liner disposed thereon.

5A provides a diagram showing how, in some embodiments, a plurality of extension legs 312 are constructed proximal to a molded hub 302 using a permanent slidable collar 314. . In some embodiments, as shown in FIG. 3B , plurality of extending legs 312 are axially seated and received within the interior cavity of permanent collar 316 . The permanent slidable collar 316 can move proximally from position A to position B due to the presence of an external force applied to the permanent slidable collar, which is provided by a plurality of extending legs 312 , clamps 306, and Luer connections 304 may have the advantage of bringing them together.

5B shows how, in some embodiments, a permanent slidable collar 316 can be used to separate the plurality of extending legs 312 from each other. In some embodiments, the permanent slidable collar 316 can move distally from point C to point D due to the presence of an external force applied to the permanent slidable collar, which is due to adhesion. In the absence of an adhesive bond such as bond 314, the plurality of extension legs 312, clamps 306 and Luer connectors 304 may be separated. In some embodiments, location A can be the same as location D, and location B can be the same as location C; This is not essential. The permanent slidable collar 316 can be moved proximally or distally along the plurality of extending legs 312 . In some embodiments, permanent slidable collar 316 can be releasably connected to molded hub 302 . Although the permanent slidable collar 316 has been described above with respect to FIGS. 5A and 5B , it should be noted that the same description applies to the attachable slidable collar 416 as well.

6A and 6B show an alternative embodiment of slidable collars in accordance with some embodiments. In some embodiments, the width 420 of the attachable slidable collar 416 can vary along the plurality of extending legs 412 . For example, in some embodiments shown in FIG. 6A , catheter assembly 400 has three extension legs 412 . The width 420 of the attachable slidable collar 416 for the catheter assembly 400 with three extension legs 412 is, in some embodiments, the width 420 of FIG. 6B with two extension legs 412. It will be different from the width 420 shown in . Width 420 may also be configured according to the size of the extension legs (eg, the diameter of each extension leg). Although the attachable slidable collar 416 has been described above with respect to FIGS. 6A and 6B , it should be noted that the same description applies to the permanent slidable collar 316 as well.

Logical flow of manufacturing

7 is a flow diagram illustrating a method 700 of manufacturing a catheter assembly for constructing extension legs, in some embodiments. In some embodiments, the method begins with obtaining a catheter assembly (block 702), which catheter assembly includes a molded hub, a catheter tube, a plurality of extension legs, and a securing mechanism. The method, in some embodiments, includes connecting the catheter tube to the molded hub and connecting the extension legs to the molded hub (block 704). The method 700, in some embodiments, includes securing the plurality of extension legs together to form an adhesive bond, for example by gluing the plurality of extension legs together (block 708), the attachable slidable Further comprising attaching a collar (block 710), attaching a permanent slidable collar (block 712), or a combination thereof. In some embodiments, bonding the plurality of extension legs together to form an adhesive bond (block 712) may be accomplished by, but not limited to, extrusion, co-extrusion, or other commonly used manufacturing processes. there is. In some embodiments, a plurality of extension legs may be glued together after extrusion to form an adhesive bond, for example through curing the plurality of extension legs together through the application of heat to the plurality of extension legs. In some embodiments, the adhesive bond may include, but is not limited to, industrial glue, spray adhesive, ultraviolet (UV) curable adhesive, and the like.

In some embodiments, the curing process includes heating the extension legs to a temperature at which the plastic outer coating begins to melt and the extension legs are then placed together. Cooling of the plastic outer coating forms an adhesive bond between the extension legs. In some examples, the plurality of extension legs that are attached together to form an adhesive bond may be subjected to a cooling step (eg, application of cooled air) prior to attachment of the attachable slidable collar or attachment of the permanent slidable collar. ) can be rough. In some examples, the plurality of extension legs may be configured as a barrier to prevent distal movement of the attachable slidable collar or the permanent slidable collar beyond the set point. Such barriers may be seated perpendicular to the direction of travel of the attachable slidable collar or permanent slidable collar and may have a height in the range of 3 to 15 mm.

In some embodiments, in attaching the attachable slidable collar (block 710) or attaching the permanent slidable collar (712), the attachable slidable collar or permanent slidable collar is initially It can be configured to bind to a molded hub, such that for any movement proximal to the molded hub, an external force must be applied to the attachable or permanent collar. In some embodiments, in attaching the attachable slidable collar (block 710) or attaching the permanent slidable collar (712), the attachable slidable collar or permanent slidable collar is initially It can be configured to be disposed at the proximal end of the plurality of extension legs, such that for any movement distal to the proximal end of the plurality of extension legs, an external force must be applied to the attachable slideable collar or the permanent slideable collar. do. In some embodiments, in attaching the attachable collar (block 710) or attaching the permanent collar (712), the attachable slidable collar or permanent slidable collar initially comprises a plurality of extended legs. It can be attached anywhere along the field.

In some embodiments, a method of fabricating a catheter assembly includes fabricating and attaching a permanent slidable collar (block 708) or fabricating and attaching an attachable slidable collar (block 710). do. In some embodiments, fabricating a permanent slidable collar (block 708) or fabricating an attachable slidable collar (block 710) may include, but are not limited to, acrylonitrile butadiene styrene, polyethylene, Polycarbonate, nylon, silicone, polytetrafluoroethylene, acetal, polyphthalamine, polyphenylene sulfide, polyetheretherketone, high-impact polystyrene, polypropylene, thermoplastic polyurethane, thermoplastic rubber, combinations thereof or those known in the art It can consist of other commonly used thermoplastics and thermoplastic derivatives used.

In some embodiments, the method of fabricating a permanent slidable collar 708 or fabricating an attachable slidable collar (block 710) may further include an outer surface comprised of a different material than the inner surface. there is. For example, the inner surface may include acetal while the outer surface may include polyethylene. In some embodiments, a method of fabricating a permanent slidable collar (block 708) or fabricating an attachable slidable collar (block 710) further comprises an outer surface composed of the same material as the inner surface. can include For example, while the inner surface may include acetal, the outer surface may also include acetal. In some embodiments, a method of fabricating a permanent slidable collar (block 708) or a method of fabricating an attachable slidable collar (block 710) includes, but is not limited to, an injection molding process, 3D printing, It can be made by urethane casting, thermoforming or other commonly used manufacturing techniques. In some embodiments, attachment of an attachable collar may occur once the catheter assembly is used by a patient. In some embodiments, once the plurality of extension legs are glued together to form an adhesive bond, the catheter assembly is packaged in disposable packaging (block 714).

Exemplary Applications of Catheter Assembly Embodiments

Referring to FIG. 8 , there is shown a diagram of a catheter assembly including a slideable collar secured to a patient using a dressing, in accordance with some embodiments. FIG. 8 shows an exemplary catheter assembly, such as catheter assembly 300 of FIG. 3 , secured to a patient's arm with a dressing 800 . As shown, the dressing 800 may include an adhesive lower side that is adhered to the patient's arm. Procedurally, the catheter assembly 300 may be placed on the patient's arm such that the catheter tip 310 is inserted into the patient at a percutaneous insertion site (marked 'X' in FIG. 8 ). After insertion of the catheter tip 310, the catheter assembly 300 may be secured to the patient's arm by placing the dressing 800 directly over the catheter tube 308 and the top of the insertion site 'X'. In some cases, dressing 800 may also be disposed over at least a portion of molded hub 302 . As shown, a slidable collar 316 may be disposed around a plurality of extended legs 312 proximal to the molded hub 302 (where proximal is to the molded hub 102, and accordingly Accordingly, the catheter tip 310 refers to the distal tip). A slidable collar 316 is shown operably disposed on a plurality of extending legs 312 proximate the molded hub 302 and the dressing 800 . Although catheter assembly 300 is shown in FIG. 8 , catheter assembly 400 may also be used with dressing 800 . Also, dressing 800 is an exemplary illustration of just one dressing; However, the disclosure is not intended to be so limiting, instead any dressing known to one skilled in the art may be used in place of dressing 800 as shown.

Referring to FIGS. 9A and 9B , perspective views of two embodiments of anchoring systems are shown. Referring to FIG. 9A , an anchoring system 900 is configured to interface with an embodiment of the present invention. The anchoring system 900 includes an anchoring device 908 , which includes an anchor pad 910 upon which a retainer 914 rests. The base of retainer 914 supports a plurality of posts and clips. Two covers 920A, 920B also extend from retainer 914 and can be moved between open and closed positions to facilitate connection with a medical device such as molded hub 902 . Retainer 914 receives, retains, and retains one or both catheter fittings (e.g., a flange extending laterally from the body of hub 902) within fixation device 908. and fixed.

As shown, a plurality of extension legs 906 are molded from hub 902 (a slidable collar 907 may be disposed proximally around plurality of extension legs 906). It extends proximal to 902 (where proximal is to molded hub 902, whereby catheter tube 904 extends distally from molded hub 902). Slidable collar 907 may take the form and characteristics of slidable collar 316 or 416 as described above.

When hub 902 is positioned in the first insertion position, fittings may be engaged with the base of retainer 914 while covers 916A, 916B extend in closure over at least some of the fittings. . When in the closed position over the fittings, covers 916A, 916B prevent lateral movement of the fittings and consequently hub 902 .

In some embodiments, a secondary cover 922 may be disposed over the rear portion 918 that includes the flange clip 924 . The secondary cover 922 is configured to rotate between open and closed positions, where the flange clip 924 engages with the latch 926 to hold the secondary cover 922 in the closed position. The clinician may apply force to separate flange clip 924 and latch 926 (which operates in the same manner as covers 916A, 916B and corresponding flange clips and latches).

The anchor pad 910 is securely attached to the patient's skin by its lower surface 912, while the retainer 914 is securely attached to the upper surface of the anchor pad 910. Anchor pad 910 may include a laminate structure with an upper plastic (eg, woven polyester), paper, or foam layer (eg, closed-cell polyethylene foam) and an underlying adhesive. provide a layer The lower adhesive layer constitutes the lower surface 912 of the anchor pad. Lower surface 912 is preferably a medical-grade adhesive and may be diaphoretic or nondiaphoretic, depending on the particular application.

Referring to FIG. 9B , an exemplary embodiment of an anchoring system 900 having prongs 920A, 920B for securing a slidable collar 907 is shown in accordance with some embodiments. As an alternative securing device for securing the slidable collar 907 to the cover 922, the retainer 914 may include prongs 920A and 920B. In embodiments where the retainer 914 is configured to mate (connect) with the slidable collar 907, the posterior portion 918 of the retainer 914 can slide when downward pressure is applied to the slidable collar 907. Possible collar 907 may include prongs 920A, 920B that releasably grip the lateral sides. The slidable collar 907 is controlled by a clinician applying a pulling force to the slidable collar 907 (or, in some cases, to the plurality of extension legs 906) of the prongs 920A, 920B. It can be removed from the phage.

Although some specific embodiments have been disclosed herein and certain embodiments have been disclosed in some detail, such specific embodiments are not intended to limit the scope of the concepts presented herein. Additional adaptations and/or modifications may be made by those skilled in the art and, in a broader sense, such adaptations and/or modifications are also included. Accordingly, adaptations and/or modifications may be made from the specific embodiments disclosed herein without departing from the scope of the concepts presented herein.

Claims (26)

As a catheter assembly for constructing a catheter system,
a molded hub comprising at least one pair of hub lumens;
a catheter tube connected to the distal end of the molded hub, the catheter tube including at least one pair of catheter tube lumens;
a plurality of extension legs each comprising a distal end connected to a proximal end of the molded hub, wherein a fluid path is formed between the catheter tube and the plurality of extension legs through the pair of hub lumens; and
a securing mechanism configured to secure the plurality of extending legs together, the securing mechanism being a slidable collar positioned on the plurality of extending legs;
including,
catheter assembly. According to claim 1,
wherein the slidable collar is a permanent collar comprising a length, a width and a height and having a proximal end with a proximal opening, a distal end with a distal opening, an outer surface and an inner surface;
catheter assembly. According to claim 2,
wherein the length is greater than or equal to the width, and the width is greater than or equal to the height;
catheter assembly. According to claim 2,
wherein the outer surface slopes toward the inner surface at a longitudinal midpoint and slopes away from the inner surface towards an end point in the longitudinal direction;
catheter assembly. According to claim 2 or 4,
the inner surface is configured to form friction with the exterior of the extending legs; and
The friction resists movement of the slidable collar in the absence of an external force applied to the slidable collar.
catheter assembly. According to claim 2 or 4,
wherein the proximal opening and the distal opening have an elliptical shape configuration;
catheter assembly. A catheter assembly for constructing a catheter system, comprising:
a shaped hub comprising at least one pair of hub lumens;
a catheter tube connected to the distal end of the molded hub, the catheter tube including at least one pair of catheter tube lumens;
a plurality of extension legs each comprising a proximal end and a distal end, the distal end of each of the extension legs being connected to the proximal end of the molded hub and passing through the pair of hub lumens to the catheter tube and the plurality of extensions A fluid path is formed between the legs; and
A securing mechanism configured to secure the plurality of extending legs together, the securing mechanism from the group consisting of a permanent slidable collar, an attachable slidable collar and an adhesion bond between the plurality of extending legs. selected -;
including,
catheter assembly. According to claim 7,
wherein the securing mechanism comprises the adhesive bond between the plurality of extending legs.
catheter assembly. According to claim 7,
wherein the fixation mechanism is the attachable slidable collar;
catheter assembly. According to claim 9,
wherein the attachable slidable collar is detachably connected to the molded hub.
catheter assembly. According to any one of claims 7 to 10,
wherein the attachable slidable collar or permanent slidable collar is positioned on the plurality of extending legs.
catheter assembly. According to any one of claims 7 to 10,
the securing mechanism is the attachable slidable collar or the permanent slidable collar; and
The fixation mechanism comprises a length, a width, a height, a proximal end with a proximal opening, a distal end with a distal opening, a midpoint in a longitudinal direction, an end point in a longitudinal direction, an outer surface and an inner surface.
catheter assembly. According to claim 12,
wherein the length is greater than or equal to the width, and the width is greater than or equal to the height;
catheter assembly. According to claim 12,
the outer surface slopes toward the inner surface at an intermediate point in the longitudinal direction and slopes away from the inner surface toward an end point in the longitudinal direction;
catheter assembly. According to claim 12,
the inner surface is configured to form friction with the exterior of the extending legs; and
wherein the friction resists movement of the attachable slidable collar in the absence of an external force applied to the attachable slidable collar.
catheter assembly. According to claim 12,
wherein the proximal opening and the distal opening are elliptical in shape;
catheter assembly. According to claim 12,
wherein the anchoring mechanism is axially separable into two separate sections;
catheter assembly. 18. The method of claim 17,
The fixing mechanism is joined at the midpoint in the longitudinal direction,
catheter assembly. According to claim 18,
wherein the anchoring mechanism is joined together by a clasping mechanism;
catheter assembly. According to claim 19,
The clasping mechanism includes a snap hook disposed in a first section and a clasp having a groove disposed in a second section, and
The groove is configured to receive the snap hook,
catheter assembly. According to claim 18,
wherein the fixing mechanism is coupled by a first pair of magnets and a second pair of magnets opposite the first pair of magnets.
catheter assembly. A method of manufacturing a catheter assembly for constructing a catheter system, comprising:
obtaining a molded hub comprising at least one pair of hub lumens, each of the hub lumens having an entry point adjacent to another entry point;
obtaining a catheter tube, the catheter tube comprising at least one pair of catheter tube lumens;
obtaining a plurality of extension legs;
obtaining a securing mechanism for securing the plurality of extension legs together, the securing mechanism selected from the group consisting of a permanent slidable collar, an attachable slidable collar and an adhesive bond;
coupling the catheter tube to the distal end of the molded hub;
coupling the distal end of each of the plurality of extension legs to the proximal end of the molded hub, forming a fluid path between the catheter tube and the plurality of extension legs through the pair of hub lumens;
securing the plurality of extension legs together using the securing mechanism; and
packaging the catheter assembly in disposable packaging;
including,
method. 23. The method of claim 22,
The step of securing the plurality of extension legs together using the securing mechanism comprises:
curing the plurality of extension legs together using heat to form the adhesive bond;
including,
method. 23. The method of claim 22,
The step of securing the plurality of extension legs together using the securing mechanism comprises:
coating the plurality of extension legs with an adhesive and curing using heat, pressure or a combination thereof to form the adhesive bond;
including,
method. 23. The method of claim 22,
The step of securing the plurality of extension legs together using the securing mechanism comprises:
attaching the permanent slidable collar;
including,
method. 23. The method of claim 22,
The step of securing the plurality of extension legs together using the securing mechanism comprises:
attaching the attachable slidable collar;
including,
method.

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